SPCs & Regulatory

We have been instrumental in developing case law, leveraging our success on behalf of our clients

SPCs & Regulatory

We file more SPCs than any other group in Europe

Our Life Sciences Group has a team with deep expertise in Supplementary Protection Certificates (SPCs) and associated pharmaceutical regulatory law. We have been filing and prosecuting SPC applications since the inception of the European patent term extension system in the 1990s. In recent years, we have been instrumental in developing SPC case law, with high value wins for our clients in the UK High Court and Court of Appeal and before the Court of Justice of the European Union. We regularly devise and implement pan-European SPC filing strategies, taking advantage of our wide experience of different practices around Europe. These strategies extend to complicated and innovative applications exploring aspects of the law that remain unclear to this day.

The timing of SPC protection is closely linked to the marketing authorisation for a pharmaceutical product in Europe. Over recent years the interplay between SPC protection and the regulatory protections that come with a new marketing authorisation, e.g. market exclusivity, data protection, orphan market exclusivity and additional terms of paediatric exclusivity, has grown considerably. The experience that we have in these cross-disciplinary issues means that we can step back and help our clients consider the wider implications of the choices and investments that they make. This expertise also informs our regular due diligence work in this area and our litigation strategies, meaning that we are involved with many of the current generation of blockbuster products.

Senior Associates

Neurim at the CJEU

When the Court of Justice of the European Union acknowledged Neurim’s right to an SPC, it overturned its own jurisprudence in a wide-ranging decision with important implications for SPC policy throughout Europe. One commentator referred to it as “the most important SPC judgment ever.”

Carpmaels & Ransford represented Neurim at the hearing before the UK IPO, and directly instructed counsel in the appeal to the UK High Court and beyond to the Court of Appeal.